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Research
Community pharmacy and pharmacist staff call center: Assessment of medication safety and effectiveness
Lisa Higgins, MPH; Mary Brown, PhD; John E. Murphy, PharmD; Daniel C. Malone, PhD, BPharm; Edward P. Armstrong, PharmD; Raymond L. Woosley, MD, PhD
J Am Pharm Assoc (2003) 2011;51:82-89. doi:10.1331/JAPhA.2011.09108

Abstract

Objective  To determine proof of concept for use of a network of pharmacists to evaluate the safety of medications.

Design  Pilot, comparative, prospective evaluation.

Setting  Community pharmacies and a pharmacist-staffed call center in Arizona during January through August 2006.

Patients  Patients filling prescriptions for ipratropium or tiotropium bromide at 1 of 55 Arizona pharmacies were encouraged to call a pharmacist-staffed call center. A total of 67 patients contacted the center and 41 participated.

Intervention  A network of community pharmacies and a call center were used to collect data on patients receiving one of two medications for the treatment of chronic obstructive pulmonary disease. Pharmacists in the community pharmacies recruited patients who presented with a prescription or requested a refill for one of the medications. The call center was used to collect patient data. Patients provided data on medication use, completed the chronic respiratory questionnaire (CRQ), and were encouraged to call the center to report health problems. After 30 days, patients were called to determine whether they experienced any adverse events while taking their medication and the CRQ was readministered.

Main outcome measure  Knowledge gained on the feasibility of the model using pharmacists to assess drug safety.

Results  A total of 67 (6.7%) of a possible 995 patients contacted the call center about participating in the study. Approximately one-half (n=28) of the 55 pharmacies had one or more patients contact the center about the study. A total of 41 patients met inclusion/exclusion criteria and were enrolled. Six (15%) patients reported an adverse effect, including one serious adverse event (acute glaucoma).

Conclusion  This study provides limited evidence that community pharmacies and a pharmacist-staffed call center can be used to assess medication safety; however, a number of issues need to be examined to determine whether the approaches can be sufficiently effective.

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References

Institute of Medicine.  The future of drug safety: promoting and protecting the health of the public. Accessed at www.iom.edu/Reports/2006/The-Future-of-Drug-Safety-Promoting-and-Protecting-the-Health-of-the-Public.aspx, September 22,  2006.
 
Jones JK. The Institute of Medicine's report on drug safety: constructive and ambitious, but does it go far enough? Clin Pharmacol Ther. 2007;81:156–8[PubMed][CrossRef]
 
Gottlieb S. Opening Pandora's pillbox: using modern information tools to improve drug safety.  Health Aff (Millwood).  2005;24:938–47[PubMed]
 
Okie S. Safety in numbers: monitoring risk in approved drugs.  N Engl J Med.  2005;352:1173–6[PubMed]
 
National Heart, Lung, and Blood Institute.  Cardiac Arrhythmia Suppression Trial (CAST). Accessed at www.clinicaltrials.gov/ct/show/NCT00000526, July 1,  2007.
 
Psaty BM, Furberg CD. COX-2 inhibitors: lessons in drug safety.  N Engl J Med.  2005;352:1133–5[PubMed]
 
Strom BL. How the US drug safety system should be changed.  JAMA.  2006;295:2072–5[PubMed]
 
 Noblis. White paper: post-licensing surveillance of the safety and effectiveness of new drugs, biologics, and devices: an action plan for the development of a national pharmacovigilance system.  Falls Church, VA:  Noblis;  2008.
 
Burwen DR, La Voie L, Braun MM, et al. Evaluating adverse events after vaccination in the Medicare population.  Pharmacoepidemiol Drug Saf.  2007;7:753–61
 
Shakir SA. Thoughts on signal detection in pharmacovigilance.  Drug Saf.  2007;30:603–6[PubMed]
 
Ferreira G. Prescription-event monitoring: developments in signal detection.  Drug Saf.  2007;30:639–41[PubMed]
 
Mann RD. Prescription-event monitoring: recent progress and future horizons. Br J Clin Pharmacol.  1998;195–201.
 
Shakir SA. Prescription-event monitoring. In: Strom BL, Ed.  Pharmacoepidemiology. 4th ed.  Hoboken, NJ:  John Wiley & Sons.  2005:203–16.
 
Borden EK, Lee JG. A methodologic study of post-marketing drug evaluation using a pharmacy-based approach.  J Chronic Dis.  1982;35:803–16[PubMed]
 
Fisher S. Patient self-monitoring: a challenging approach to pharmacoepidemiology. Pharmacoepidemiol Drug Saf.  1995;4:359–78
 
Abarca J, Malone DC, Armstrong EP, et al. Angiotensin-converting enzyme inhibitor therapy in patients with heart failure enrolled in a managed care organization: effect on costs and probability of hospitalization.  Pharmacotherapy.  2004;24:351–7[PubMed]
 
Kubo SH, Schulman S, Starling RC, et al. Development and validation of a patient questionnaire to determine New York Heart Association classification.  J Card Fail.  2004;10:228–35[PubMed]
 
Rector TS, Francis GS, Cohn JN. Patients' self-assessment of their congestive heart failure: part 1: patient perceived dysfunction and its poor correlation with maximal exercise tests.  Heart Fail.  1987;3:192–6
 
Rector TS, Kubo SH, Cohn JN. Patients' self-assessment of their congestive heart failure: part 2: content, reliability and validity of a new measure, the Minnesota Living with Heart Failure questionnaire.  Heart Fail.  1987;3:198–209
 
Kitzinger J. The methodology of focus groups: the importance of interactions between research participants. Sociol Health Illn.  1994;16:103–21
 
Basch CE. Focus group interview: an underutilized research technique for improving theory and practice in health education. Health Educ Q.  1987;14:411–8[PubMed]
 
Stewart DW, Shamdasain PN. Focus groups: theory and practice.  Newbury Park, CA:  Sage;  1990.
 
Bender DE, Ewbank D. Focus groups for health research.  Health Transit Rev.  1994;4:63–79[PubMed]
 
Schünemann HJ, Griffith L, Jaeschke R, et al. A comparison of the original chronic respiratory questionnaire with a standardized version.  Chest.  2003;124:1421–9[PubMed]
 
Guyatt GH, Schünemann HJ. Chronic respiratory questionnaire.  Hamilton, Canada:  McMaster University;  2001.
 
Lacasse Y, Guyatt G, Goldstein RS. Is there really a controversy surrounding the effectiveness of respiratory rehabilitation in COPD? Chest.  1998;114:1–4[PubMed]
 
Quantitative Software Management.  Clinical pharmacology: version 2.20: 2006 Gold Standard. Accessed at www.clinicalpharmacology.com/forms/login.aspx, July 1,  2007.
 
Food and Drug Administration.  Public health advisory: important information on the correct use of Spiriva and Foradil capsules. Accessed at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm051132.html, August 1,  2008.
 
Food and Drug Administration.  Follow-up to the October 2008 updated early communication about an ongoing safety review of tiotropium (marketed as Spiriva HandiHaler). Accessed at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm197429.htm, August 1,  2008.
 
Hepler CD, Strand LM, Tromp D, Sakolchai S. Critically examining pharmaceutical care.  J Am Pharm Assoc.  2002;42(5 suppl 1):S18–9.
 
McDonough RP, Doucette WR. Drug therapy management: an empirical report of drug therapy problems, pharmacists' interventions, and results of pharmacists' actions.  J Am Pharm Assoc.  2003;43:511–8
 
Schumock GT, Butler MG, Meek PD, et al. Evidence of the economic benefit of clinical pharmacy services: 1996-2000.  Pharmacotherapy.  2003;23:113–32[PubMed]
 
Carter BL, Helling DK. Ambulatory care pharmacy services: has the agenda changed? Ann Pharmacother.  2000;34:772–87[PubMed]
 
Schumock GT, Meek PD, Ploetz PA, et al. Economic evaluations of clinical pharmacy services: 1988-1995: the Publications Committee of the American College of Clinical Pharmacy.  Pharmacotherapy.  1996;16:1188–208[PubMed]
 
Carter BL, Helling DK. Ambulatory care pharmacy services: the incomplete agenda. Ann Pharmacother.  1992;26:701–8[PubMed]
 
Bunting BA, Smith BH, Sutherland SE. The Asheville Project: clinical and economic outcomes of a community-based long-term medication therapy management program for hypertension and dyslipidemia.  J Am Pharm Assoc.  2008;48:23–31
 
Lewis N, Bugdalski-Stutrud C, Abate The Medication Assessment Program: comprehensive medication assessments for persons taking multiple medications for chronic diseases. J Am Pharm Assoc.  2008;48:171–80
 
Isetts BJ, Schondelmeyer SW, Artz MB, et al. Clinical and economic outcomes of medication therapy management services: the Minnesota experience.  J Am Pharm Assoc.  2008;48:203–11
 
Johnson CL, Nicholas A, Divine H, et al. Outcomes from DiabetesCARE: a pharmacist-provided diabetes management service.  J Am Pharm Assoc.  2008;48:722–30
 
Christensen DB, Hansen RW. Characteristics of pharmacies and pharmacists associated with the provision of cognitive services in the community setting.  J Am Pharm Assoc.  1999;39:640–9
 
Christensen DB. Lessons learned from the Washington State CARE Project.  J Am Pharm Assoc.  1999;39:606–7.
 
Stergachis A, Gardner JS, Anderson MT, et al. Improving pediatric asthma outcomes in the community setting: does pharmaceutical care make a difference? J Am Pharm Assoc.  2002;42:743–52
 
Weinberger M, Murray MD, Marrero DG, et al. Effectiveness of pharmacist care for patients with reactive airways disease: a randomized controlled trial.  JAMA.  2002;288:1594–602[PubMed]
 
Cranor CW, Bunting BA, Christensen DB. The Asheville Project: long-term clinical and economic outcomes of a community pharmacy diabetes care program.  J Am Pharm Assoc.  2003;43:173–84
 
Tsuyuki RT, Olson KL, Dubyk AM, et al. Effect of community pharmacist intervention on cholesterol levels in patients at high risk of cardiovascular events: the Second Study of Cardiovascular Risk Intervention by Pharmacists (SCRIP-plus).  Am J Med.  2004;116:130–3[PubMed]
 
McLean WM, MacKeigan LD. When does pharmaceutical care impact health outcomes? A comparison of community pharmacy-based studies of pharmaceutical care for patients with asthma. Am Pharm.  2005;39:625–31
 
McLean W, Gillis J, Waller R. The BC Community Pharmacy Asthma Study: a study of clinical, economic and holistic outcomes influenced by an asthma care protocol provided by specially trained community pharmacists in British Columbia.  C Respir J.  2003;10:195–202
 
Schulz M, Verheyen F, Muhlig S, et al. Pharmaceutical care services for asthma patients: a controlled intervention study.  J Clin Pharmacol.  2001;41:668–76[PubMed]
 
Weinberger M, Murray MD, Marrero DG, et al. Issues in conducting randomized controlled trials of health services research interventions in nonacademic practice settings: the case of retail pharmacies.  Health Serv Res.  2002;37:1067–77[PubMed]
 
Manasse HR, Thompson KK. Medication safety: a guide for health care facilities.  Bethesda, MD:  American Society of Health-System Pharmacists;  2006:291–8.
 
Wittkowsky AK, Nutescu EA, Blackburn J, et al. Outcomes of oral anticoagulant therapy managed by telephone vs in-office visits in an anticoagulation clinic setting.  Chest.  2006;130:1385–9[PubMed]
 
Tierney WM, Oppenheimer CC, Hudson BL, et al. A national survey of primary care practice-based research networks.  Ann Fam Med.  2007;5:242–50[PubMed]
 
Zafar A, Tierney W, Hickner J, Pace W. An adverse drug event and medication error reporting system for ambulatory care.  AMIA Annu Symp Proc.  2008.839–43.
 
Heal CF, Veitch C, Preston R. Practice based research: lessons from the field.  Aust Fam Physician.  2008;37:381–4[PubMed]
 
Pruchnicki MC, Rodis JL, Beatty SJ, et al. Practice-based research network as a research training model for community/ambulatory pharmacy residents.  J Am Pharm Assoc.  2008;48:191–202
 
Kuo GM, Steinbauer JR, Spann SJ. Conducting medication safety research projects in a primary care physician practice-based research network.  J Am Pharm Assoc.  2008;48:163–70
 
Goode JV, Mott DA, Chater R. Collaborations to facilitate success of community pharmacy practice-based research networks.  J Am Pharm Assoc.  2008;48:153–62
 
Lipowski EE. Pharmacy practice-based research networks: why, what, who, and how. J Am Pharm Assoc.  2008;48:142–52
 
Dickerson LM, Kraus C, Kuo GM, et al. Formation of a primary care pharmacist practice-based research network.  Am J Health Syst Pharm.  2007;64:2044–9[PubMed]
 
van Grootheest AC, de Jong-van den Berg LT. The role of hospital and community pharmacists in pharmacovigilance.  Res Social Adm Pharm.  2005;1:126–33[PubMed]
 
Food and Drug Administration.  Innovation or stagnation: challenge and opportunity on the critical path to new medical products.  Washington, DC:  Food and Drug Administration;  2004.
 
Food and Drug Administration.  FDA's Sentinel Initiative: background. Accessed at www.fda.gov/Safety/FDAsSentinelInitiative/ucm149340.htm, January 19,  2010.
 
Wu Y, Mackuch RW. Detecting rare adverse events in postmarketing studies: sample size considerations.  Drug Inf J.  2006;40:89–98
 
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